Regulatory Affairs Specialist

SUMMARY:
A Leading Company is currently seeking a Regulatory Affairs Specialist to join their extraordinary team.

POSITION INFO:

Minimum Requirements:

• 3 – 5 years’ experience as a Regulatory Affairs Specialist

• Maintenance of and submission of amendments to South African registered product dossiers (in compliance with SAHPRA requirements - includes dossier conversions).
• Screening, compilation and registration of new multisource (generic) products in eCTD format for the South African market.
• Support to the Export Division with respect to SSA submissions.
• Communication with SAHPRA and other relevant health authorities.
• Competency with e-Submission requirements as per SAHPRA requirements for new and existing applications.
• Competency and administration of the DocuBridge programme to submit eCTD applications and ensure dossier life cycle management as per SAHPRA requirements.
• Training of RA personnel, as and when identified.
• Assist with preparation of audits (internal & external) to ensure compliance.
• Assist with any compliance related activities as identified by line manager.
• Keep abreast of new developments in legislation, guidelines and recommendations of SAPHRA.
• Acquire and maintain technical knowledge and skills relevant to the position by keeping abreast of current literature and attending academic seminars/meetings with respect to new developments in the regulatory affairs and pharmacovigilance arena.

Let us take your CAREER to the next level!                                           

Our innovative strategy and continuous streamlining of processes ensure we stand out from our competitors.

For more exciting positions visit our website www.higherintelligence.co.za or give the specialist recruitment consultant a call on JHB 011 -442-0633.

Please note if you have not received feedback within two weeks please consider your application unsuccessful.                                              

NB! This job is now closed. You can apply for other jobs by uploading your CV.